Issue link: https://www.e-digitaleditions.com/i/883179
Tablets & Capsules October 2017 29 effort to purify the API. For $100,000, I can get a wiped- film evaporator and distill my API to better than 90 per- cent purity, which we call distillate. THC and other cannabinoids at 90 percent purity are very viscous liquids or semisolids at room temperature. Distillate is often preferred for its clarity and purity and is still a candidate for a SEDDS formulation. Heated to near 100°C, the distillate's viscosity decreases and it becomes more liquid, but keep in mind that heat and oxygen pro- mote degradation. For insight on mitigating that, break out your excipient handbook or call some colleagues to reacquaint yourself with preservatives and stability enhancement. As with oil, distillate can—with diffi- culty—be loaded directly into capsules or, preferably, diluted with coconut oil, other medium-chain triglyc- erides, or liquid PEG and handled as a viscous liquid. Making tablets by loading this very viscous API into a powder, however, is not widely practiced. But where there is a will—or significant incentive—there is usually a way. Just don't expect it to happen in your production V- type blender. With increasing purity comes smaller dosage forms. If we're filling capsules, we just go to a smaller capsule. But be quick about filling them so you don't expose the API too long to high temperatures because it may degrade. For 10 mg tablets, which I don't consider "low dose" in the usual sense, you still need to pay attention and use a sensi- ble approach. That includes using materials that blend well so you can use low-dose and geometric blending techniques. Also consider using a very, very wide particle size distribution to help stabilize your content uniformity. Formulating with CBD Because CBD does not have the legal implications of THC—it has no psychoactive implications—many more formulation strategies are available. CBD exists as an oil at lower purities, a wax at higher purities, and a crystalline solid at its highest purity. Much of the CBD found on the market is isolated from hemp instead of cannabis, so it contains much less THC and other cannabinoids. Purified CBD crystals are commercially available as a 99.9 percent pure material. This is great if your state's regulations allow you to source and use these materials. At my company's New York operation, we cannot use any cannabinoids unless we isolate them directly from plants that we our- selves have grown at a state-approved facility. Any addi- tives we use must meet USP/NF standards. Formulating CBD tablets can be straightforward if you use the crystalline form of the API. Here again, higher purity may equal lower stability depending on your for- mulation, so use conventional stability enhancement methods and sensible packaging. Many people are interested in formulating particular cannabinoid profiles, and many of the formulations on the #©¹£©ªÆĺG1ĺ¯ªÆ¼¯£ĺĺ "7#ĺS¯Ê|ĺN|¼ª ðë 8ĺ¯©¹¼ÀÀ¯ªĺ¯¼| SN7ĺĘĺĺŜĺşĺS¯¯£ª #ªÀƼʩªÆĺÔÆĺĵ¼|Ư¼ĺ£pÀÀ|Ķĺ ªÀƼʩªÆpƯªĺÀÚÀÆ© SĺªÙÆĺª¼pƯªĺ Àĺ¼Ě Ù¹¼ª|ĺ ÆĺÓ¯£ÊƯªĝĝĝ N¹|p£ÆÚĺ7pÀʼ©ªÆÀĺ#ª|ĝ a{ÀÆėĺÔÔÔĝÀ©Æ©|ĝ|¯© G¯ªėĺŖìĺĪôëóīĺðîïĮìðëë -¯ªĺÊÀĺpÆĺGNĚ 8¯Ó©{¼ĺìîĮìðĘĺíëìò Npªĺ¯ĺ¯ªÓªÆ¯ªĺªÆ¼Ęĺ Npªĺ¯ĺp£¯¼ªp ¯¯Æĺ8¯ĝĺíëëñ ~Ds_ ĺĺĺS=W"